Reducing Human Error in Life Sciences Manufacturing: 5 Opportunities for Improvement

Human error is cited as the cause of most deviations by FDA-regulated manufacturers. Yet these people problems are probably not as prevalent as cited. Problems caused by human error, particularly those that occur again and again, are problems that need deeper investigation. Often there are processes or systems in place that keep producing a problem that root cause analysis could resolve.

Yes, human error is inevitable but  there are ways to keep it and the factors that influence it in check. People problems can be minimized by addressing specific factors on an organizational and an individual level.

  1. Triggers and Processes: Do expectations match capabilities? Defining when a certain capability is required and how it integrates within the current workflow can ensure that the people and processes are in place to meet expectations and that the processes are realistic and achievable. Triggers that indicate when standard procedures have not been followed, alert people to get back on track, minimizing deviations and maintaining quality.
  2. Performance Alignment: Aligning goals, consequences and feedback with desired behaviors ensures high performance. Are people being asked to meet realistic goals or will performance suffer in pursuit of unrealistic standards? Aligning goals such as output and quality help people meet their expectations without undue stress on them and on the organization. . People need to understand their expectations as well as the impacts to them and to the organization of not meeting them. Coaching can help people to adapt to their specific work requirements and become more proficient. Clearly defined performance expectations minimize the confusion or struggles that result in human error that can affect quality.
  3. Rewards not Punishment: There are often impacts that punish identifying problems and engaging in root cause analysis. In many firms, whoever notices the deviation is responsible for its resolution, which can be an onerous task on top of regular responsibilities. Letting something slip unnoticed could be the easier solution. People need to be rewarded for the pursuit of quality and invested in resolving problems and pursuing improvements by accommodating problem solving efforts and recognizing their results.
  4. Employee Investment: An organization with high expectations for employee performance should be ready to invest in people and support them on the job. If people problems are pervasive, it is time to step back and review the landscape. A high-performance culture is one where achievements in pursuit of quality are celebrated and maintained. When too many “people problems” occur, it is time to address employee capabilities, review standard procedures to ensure that they align with employee capabilities and invest in the improvements that are needed.
  5. Personal Mastery:  According to systems scientist Peter Senge, in his research on learning organizations (The Fifth Discipline), personal mastery is an essential part of staying competitive in today’s changing environment.  Personal mastery relates to expanding the ability to be more productive by learning how to apply skills in the most valuable way. He notes that “even with the best training programs, most learning in the workplace is incidental, rather than the product of formal training.”  Therefore, it is important to build a sense of purpose and a commitment to the pursuit of quality on the job and to support continuous learning. This lays the groundwork for greater human performance and, in turn, less human error.

When human error is to blame, corrective actions should involve addressing the system itself—its balance of consequences, feedback mechanisms, targets and objectives. In short, the solution lies with improving human performance by addressing ways to align rewards, measures and behavior in pursuit of performance.

About Kepner-Tregoe

Kepner-Tregoe has been the industry leader in problem-solving and service-excellence processes for more than 60 years. The experts at KT have helped companies raise their level of incident- and problem-management performance through tools, training and consulting – leading to highly effective service-management teams ready to respond to your company’s most critical issues.

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